1. Field of the Invention
This invention relates to flexible medical container packaging of aqueous solutions requiring protection form environmental effects of UV lights such as omitted by the sun and fluorescent lights. More particularly, the invention relates to the packaging of fluids such as certain liquid pharmaceutical formulations and diagnostic contrast media sensitive to UV lights in a container which maintains its configuration when filled but flexibly collapses as the fluids are being administered to patients.
2. Reported Developments
Flexible medical containers are known in the art for the containment and delivery of medical fluids. Such containers serve for accommodating blood or for sterile storage of infusion solutions and diagnostic media for parenteral administration. For these purposes the containers must be sterile and sterility is achieved by heating to at least 100.degree. C. or more in an autoclave. Sterility must be maintained during storage and administration of the medical fluids such that environmental conditions such as atmospheric oxidation will not jeopardize the integrity of the medical fluids.
In order to maintain the integrity of the medical fluids both during the sterilization process and storage, the medical bag is packaged in a first packaging material or overwrap having sufficient gas permeability and heat resistance able to withstand heat on autoclaving, and a second packaging material or overwarp which has a high oxygen impermeability. This double packaging results in good shelf life, such as disclosed, for example in U.S. Pat. No. 4,548,605. Other efforts to maintain the integrity of medical fluids during and subsequent to sterilization included the use of multi-layer packaging, such as disclosed in U.S. Pat. No. 4,660,721. Still other efforts included the use of a deoxidizer between the medical fluid-filled container and the outer wrap which outer wrap covers both the container and the deoxidizer.
Certain medical fluids are not only oxygen-sensitive, but also light-sensitive. To prevent TV rays reaching the ophthalmic solution in a vessel, U.S. Pat. No. 4,150,744 discloses the use of a laminate comprising nylon, aluminum foil and polypropylene with which the vessel is overwrapped. Such laminates, containing a metal foil widely used for pouches and bags containing intravenous solutions. However, there is also a need to allow observation of the content of the medical bags during the filling operation and delivery thereof to the patient. To satisfy that need transparent polymeric materials are used. However, such transparent polymeric materials are not sufficient barriers to UV rays.
It would be highly desirable to provide a medical bottle packaged in an overwrap having UV barrier properties yet which would allow observation of the content of the bottle as well as the identifying inscription on the bottle without removing the overwrap.
Such identifying inscription on the medical bottle itself would also reduce errors which may occur during packaging of the medical bottle in an overwrap when the medical bottle and the overwrap are manufactured in different manufacturing operation or at different manufacturing sites.
Applicants have now discovered that, in addition to providing a medical container having the required properties to allow autoclave sterilization, may be packaged in an overwrap which is substantially resistant to UV rays penetration, yet allow viewing the content of the medical bottle and its identifying inscription.